Renal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)

This study has been completed.

Sponsor:

Collaborator:

Ministry of Science and Higher Education, Poland

Information provided by:

Institute of Cardiology, Warsaw, Poland

ClinicalTrials.gov Identifier:

NCT01128933

First received: May 21, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 21, 2010

Last Updated Date

May 21, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood pressure improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Kidney function preservation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Fractional Flow Reserve in Renal Artery Stenting

Official Title ^ICMJE

Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting

Brief Summary

The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Artery Stenosis
Hypertension

Intervention ^ICMJE

Procedure: Renal artery stenting

Study Arm (s)

Experimental: Hypertensive patients

Hypertensive patients with at least moderate renal artery stenosis

Intervention: Procedure: Renal artery stenting

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
Hypertension defined according to WHO criteria
Age 18-75 years
Signed informed consent obtained

Exclusion Criteria:

Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
Contraindications to percutaneous renal angioplasty with stenting
Atrophy of the kidney supplied with stenosed artery
Other well known secondary reason for hypertension
Chronic heart failure NYHA II-IV
Significant valvular heart disease qualified for surgery
Persistent atrial fibrillation
Renal failure with GFR below 30ml/min

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT01128933

Other Study ID Numbers ^ICMJE

2P05B02530

Has Data Monitoring Committee

Responsible Party

Jacek Kadziela, Institute of Cardiology, Warsaw, Poland

Study Sponsor ^ICMJE

Institute of Cardiology, Warsaw, Poland

Collaborators ^ICMJE

Ministry of Science and Higher Education, Poland

Investigators ^ICMJE

Principal Investigator:	Jacek Kadziela, MD,PhD	Institute of Cardiology, Warsaw, Poland
Principal Investigator:	Adam Witkowski, Prof	Institute of Cardiology, Warsaw, Poland
Principal Investigator:	Andrzej Januszewicz, Prof	Institute of Cardiology, Warsaw, Poland

Information Provided By

Institute of Cardiology, Warsaw, Poland

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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